Rx Item-Briminidine-Timolol Gen Combigan Drops 10Ml By Sandoz Pharma

Clinical Information
Gen. Code and Des.
53407 brimonidine tartrate/timolol OPHTHALMIC DROPS 0.2%-0.5%
GCN and Des.
20876 brimonidine tartrate/timolol OPHTHALMIC DROPS 0.2%-0.5%
Strength
0.2-0.5%
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
52400400 ALPHA-ADRENERGIC AGONISTS (EENT)
52400800 BETA-ADRENERGIC BLOCKING AGENTS (EENT)
Active Ingredients
1856 timolol maleate 26921175
6197 brimonidine tartrate 70359465
Inactive Ingredients
3141 benzalkonium chloride 8001545
FDA NDA Approved

COMBIGAN- brimonidine tartrate and timolol maleate solution/ drops
Allergan, Inc.

1 INDICATIONS AND USAGE

COMBIGAN� (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN� dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

2 DOSAGE AND ADMINISTRATION



The recommended dose is one drop of COMBIGAN� in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.

3 DOSAGE FORMS AND STRENGTHS

Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol (6.8 mg/mL timolol maleate).

RX ITEM-Gen Combigan -Sandoz
Item No.:rx743647 743647 NDC No.00781-7186-70 0781-7186-70 00781718670 0781718670 UPC/GTIN No. 3-70436-02582-4 370436-025824 370436025824 MPN 8670

Combigan 0.2% 0.5% Drops 10Ml By Allerga
BRAND: COMBIGAN NDC: 00023-9211-10,23921110 UPC: 3-00239-21110-6,300239211106 Allergan USA, Inc.

BRIMONIDINE TARTRATE/TIMO
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